DiGA as a Medical Device (MDR): Requirements & Differences
Since 2019, around 73 million people with statutory health insurance in Germany have been entitled to digital health applications (DiGA): the so-called “app on prescription.” However, the interaction between DiGA and medical device regulations often causes confusion...
Interoperability for Digital Health Applications (DiGA)
We would like to briefly introduce the topic of interoperability in DiGA development with a small example: “Μια DiGA πρέπει να πληροί ορισμένες απαιτήσεις διαλειτουργικότητας.” Do you understand this sentence? Unless you speak Greek, probably not. You therefore need...
DiGA price negotiations with the GKV-Spitzenverband
The development of a digital health application (DiGA) costs time and money and involves many regulatory hurdles. As a manufacturer, you naturally have an interest in ensuring that this effort pays off in the end. You probably already know that even if your...
DiGA Revenue & Costs: Is a DiGA worthwhile?
As with any business idea, the financial potential of a DiGA project should be calculated at the outset. A central question arises: Is the development of your DiGA idea worthwhile for you? Potential investors for your DiGA project are also asking themselves this...
Guide for DiGA Marketing and Sales
With all regulatory parameters fulfilled and entry into the central DiGA directory, are all hurdles cleared and successful market entry guaranteed? Unfortunately, not quite. Contrary to some wishful thinking, entry into the central DiGA directory itself does not mean...
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